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About the Role

The Lead Regulatory Affairs Specialist ensures that medical devices and their development, testing, and marketing processes meet all applicable regulatory requirements. This role is responsible for timely regulatory submissions and approvals for placing and maintaining devices on the market, anticipating tasks, and coordinating cross-functional teams.

Responsibilities

• Manage or be responsible for compiling approval-relevant documents, including free sales certificates, legalizations, other declarations, and certificates.
• Manage or be responsible for compiling documents for documentation evaluations by notified bodies and competent authorities worldwide.
• Manage or be responsible for the control/acceptance of technical documentation as part of the conformity assessment procedure, including assessment of compliance with essential requirements and preparation/release of declarations of conformity.
• Support the development and updating of design control processes, and parallel applicable processes and guidelines.
• Provide subject-specific involvement in the implementation of the risk management process, clinical evaluation, and usability file.
• Control and hold sole responsibility for reviewing/releasing approval-relevant documents within the design control process, specifically Risk analysis/risk management, clinical evaluation, design validation/design verification plans and protocols, software documentation, instructions for use, and product labeling.
• Manage or be responsible for the regulatory evaluation of change orders and checking for approval relevance.
• Manage or be responsible for processing RA-related general inquiries.
• Act as Subject Matter Expert for the interpretation of standard requirements, such as clinical evaluation, biocompatibility, electrical safety, and cyber security.
• Serve as the interface between RA departments of customers, the notified body, and authorities.
• Support audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR.
• Process safety-related complaints in cooperation with the Medical Affairs team.
• Initiate and monitor processing of measures to maintain the QMS (e.g., process adaptation).
• Ensure strict compliance with quality, occupational safety, and environmental regulations.
• Implement the instructions of the quality/environmental management representative and the occupational safety specialist.

Requirements

• Long-term (5-8 years) of extensive and well-founded functional professional experience.
• Willingness to travel up to 10% to different NOVT locations and business partners.

Skills

• Quality-oriented
• Reliable
• Dependable
• Self-motivated
• Team player
• Independent
• Self-reliant
• Excellent communication skills
• Well-structured and systematic way of working

Location

• The Americas
• Europe
• Asia-Pacific

Work Type

• Full-time

Experience Level

• 5-8 years

Education Level

• Completed studies in the natural sciences, engineering, medical or comparable field
• Advanced training “Manager Regulatory Affairs for Medical Devices”

About the Company

• At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible.
• We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.
• Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific.
• We have a culture that embraces teamwork, collaboration and empowerment.
• This position is part of Novanta’s Advanced Surgery business unit.
• Specialized in the field of Minimally Invasive Medicine, Novanta Medical develops devices and accessories so that doctors can operate with small cuts.
• We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone.
• Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures.
• Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate.

Equal Opportunity

• Novanta is proud to be an equal employment opportunity and affirmative action workplace.
• We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.
• Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.